Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB)
NCT00079586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2012-01-05
Summary
The purpose of this study is to demonstrate that in patients undergoing coronary artery bypass grafting (CABG) or CABG-Valve, or Isolated Cardiac Valve surgery on CPB (cardiac surgery), Angiomax is a safe and effective alternative anticoagulant to heparin with protamine reversal.
Conditions
- Cardiovascular Disease
- Coronary Artery Bypass Surgery
Interventions
- DRUG
-
Heparin
Unfractionated Heparin per institutional practice
- DRUG
-
Bivalirudin
1.0 mg/kg IV bolus followed by a 2.5 mg/kg/hr IV infusion
Sponsors & Collaborators
-
The Medicines Company
lead INDUSTRY
Principal Investigators
-
Malcolm Lloyd, MD · The Medicines Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-04-30
- Completion
- 2004-11-30
Countries
- United States
Study Locations
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